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NCT04374188 Clinical Trial

Efficacy of Ciprofloxacin Therapy in Avoidance of Sepsis in Patient Undergoing Percutanous Nephrolithotomy

Nephrolithiasis Clinical Trial

Official title:
Efficacy of Ciprofloxacin Therapy in Avoidance of Sepsis in Patient Undergoing Percutanous Nephrolithotomy: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04374188
Other study ID # RS/19.23
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 1, 2019
Est. completion date March 1, 2022

Study information
Verified date March 2021
Source Kafrelsheikh University
Contact Diaa Eldin Taha, MD
Phone 01008531384
Email drdiaaeldin@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Efficacy of ciprofloxacin therapy in avoidance of sepsis in patient undergoing percutanous nephrolithotomy. A randomized controlled trial.

Description:

To figure out the value of oral ciprofloxacin medication in ameliorate the outcome of renal nephrolithiasis extraction via the endoscope as regard the sepsis.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date March 1, 2022
Est. primary completion date September 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 1. Patient 18 years or older - Stones = 2 cm and/or mild to moderate hydronephrosis - Sterile mid urine stream Exclusion Criteria: - Patients with a stent, nephrostomy tube or indwelling catheter - Renal failure - Fever before surgery - Previous manipulation/procedure - Concomitant bladder stone or tumour - Patients with active UTI - Contralateral renal/ureteric stone

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Ciprofloxacin
drug adminstration to ameliorate sepsis incidence
• Levofloxacin
levofloxacin pill

Locations
Country Name City State
Egypt Kafrelsheikh faculty of medicine Kafr Ash Shaykh Kafrelsheikh

Sponsors (1)
Lead Sponsor Collaborator
Diaa Eldin Taha Ramadan Mohamed

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Effect of ciprofloxacin versus levofloxacin duration before PCNL To evaluate whether 7 days of ciprofloxacin or levofloxacin before PCNL, can reduce upper urinary tract infection and urosepsis after PCNL. 12 months
Secondary differences between Culture and sensitivity (C&S) of Preoperative urine (MSU) and intraoperative renal pelvic urine Compare the difference between C&S of Preoperative urine (MSU) and intraoperative renal pelvic urine and extracted stone, in predicting the upper urinary tract infection and urosepsis. 12 months
Secondary predictors of systemic inflammatory response syndeome (SIRS) and sepsis post PCNL. assess the risk factors for SIRS and sepsis in PCNL. 12 months
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